Determination of the docetaxel content by ultra performance liquid chromatography technology

Objective Ultra performance liquid chromatography (UPLC) was established to determine the content of docetaxel in docetaxel injection in order to control the quality of docetaxel and to ensure the rational use of the drug. Methods The chromatographic conditions:Hypersll BDS C18 column (2.1×100 mm, 3 μm), equilibrated with methanol-water (55:45, V/V), flow rate:0.4 ml/min, column temperature:30℃, amount of sample:10 μl, and the analysis wave length:230 nm. The standard solution of paclitaxel, docetaxel and docetaxel blanks were mixed, and the specificity was verified. The docetaxel working fluid was set up in a concentration of docetaxel, and the docetaxel standard curve was established by determining the peak area ratio of docetaxel and paclitaxel. The docetaxel Quality control samples, each concentration of 5 copies, for precision verification; in the blank material solution, add the appropriate amount of docetaxel and paclitaxel, configure the quality control samples, each concentration of 6 copies, the recovery rate verification; configuration quality control Samples were prepared at each concentration of 6 parts, were placed for 24 h, repeated freezing and thawing 3 times, -20℃ for one week after the injection determination, stability verification; The dosage of docetaxel was dispensed into 3 μg/ml solution, and 3 parts were placed in parallel. The content of docetaxel in docetaxel was measured. Results Docetaxel had a good linearity in the range of 0.06-10 μg/ml (R²=0.999 7), which was verified by specificity, precision, recovery and stability, and met the requirements. His race content was 99.4%, 98.7% and 101.5%, respectively. Conclusion UPLC method established by this experiment can be used quickly and sensitively to determine the content of docetaxel.